CTRI/2023/10/058791进行中（未招募）4 期
A prospective, single-arm, open-label, multicentre, phase IV clinical trial to assess the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate, Budesonide dry powder for inhalation (DPI) in patients with Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Change in trough FEV1
研究概览
简要总结
This will be prospective, single-arm, open-label, multicentre, phase IV clinical trial to assess the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate & Budesonide dry powder for inhalation (DPI) in patients with Chronic Obstructive Pulmonary Disease aged 40 to 65 years in India. The study will enroll approximately 200 subjects to receive study drug. Study treatment duration would be 12 weeks and there will be 5 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex between 40-65 years of age (both inclusive).
- •Patients who are current/ex-smokers.
- •Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: • Post-bronchodilator FEV1/FVC ratio < 0.7 • Post-bronchodilator FEV1, ≥ 30% to < 80% predicted
- •COPD Assessment Test (CATTM) score ≥ 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4 weeks at the time of screening.
- •Written informed consent from the patient.
- •Patients literate enough to fill the diary card and willing to comply with the protocol requirements.
排除标准
- •1.Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
- •Patients with known α1 antitrypsin deficiency
- •Patients diagnosed with COVID-19 in last 3 months
- •COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period
- •Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period
- •Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period
- •Patients who required long-term oxygen therapy (≥12 hours/day) within 4 weeks prior to the screening or during the screening period
- •Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention
- •Patients with known hypersensitivity to formoterol glycopyrronium, salbutamol, other beta-2 agonists or other antimuscarinic agents
- •Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy
- •Patients with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl) at screening
- •Patients with continuing history of alcohol and/or drug abuse
- •Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception
- •Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
Change in trough FEV1
时间窗: At 4 weeks & 12 weeks
次要结局
- 1.Change in trough FVC(2.Change in post-bronchodilator FEV1 & FVC)
- Safety endpoints(• Adverse events reported during the study)
研究者
研究点 (7)
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